Device and method for fecal testing

ABSTRACT

A specimen testing device having a first panel with at least two apertures, a second panel with at least two apertures opposite the apertures in said first panel, a sheet disposed between the first and second panels for receiving a specimen through the apertures, the sheet in the apertures in said first panel having first, second and third portions disposed on opposite sides of a longitudinal axis of the apertures. First aperture covers are mounted on the first panel and overlie the apertures in the first panel. Second aperture covers are mounted on the second panel and overlie the apertures in the second panel. The first and second aperture covers in the first and second panels are movable independently of each other to expose the first, second and third portions of the sheet.

The present invention relates to a device for testing fecal matter, andto a method of testing using such a device.

BACKGROUND OF THE INVENTION

It is well known that colorectal cancer and large polyps bleed into thestool. Use of guaiacum for the detection of blood. was described. in“The Scarlet Letter” by Sherlock Holmes as being sensitive butunreliable. The problem has been that guaiacum detects oxidizing agentsof which blood is only one, and red meat and other oxidizing agents alsocan test positive.

A typical form of fecal occult blood testing known as Hemoccult II®utilizes a guaiac-treated test sheet upon which a specimen of fecalmaterial is smeared. A developing solution is applied to the oppositeside of the sheet yielding a blue color, which suggests that blood maybe present in the fecal specimen. The drawback of this approach is thata high percentage of false positives is obtained from patients who infact do not have a cancer or polyp. A false positive result in the testoften results in expensive testing of patients who in fact have simplyconsumed a lot of meat just prior to the test.

One approach to overcome the high incidence of false positives has beento make the test paper sensitive enough to detect up to 2% of blood butnot sensitive enough to produce too many false positives. A disadvantageof this compromise approach is that because of the reduced sensitivity,a number of cancers and polyps are not detected.

In an effort to increase sensitivity, the Hemoccult® SENSA system wasdevised (which results in detecting as little as 1000 micrograms ofblood per ml of stool). However, this system results in a higherincidence of false positives requiring unnecessary invasive tests.

Alternative approaches to cutting down on false positives have involvedplacing patients on specific diets designed to restrict intake of animalproteins and other sources of false positives. Despite these efforts,large numbers of false positives still occur. One reason for this is thevery long time it can take for food to pass through the bowel in certainpatients.

A specific test for human hemoglobin has been devised. This test —theHemeSelect® test (now called Immudia-sp®)—theoretically registers onlyhuman hemoglobin and not animal blood from meat or other agents andtherefore theoretically does not require the patient to be on a specialdiet. Another possible advantage is that human blood from the uppergastrointestinal tract may be digested by the time it reaches the stooland the only human blood detected would be that from the distal bowel. Aserious drawback of the Immudia-sp® test is that it is expensive for ascreening test and requires specially trained individuals to perform andread the test.

Devices and method for screening fecal occult blood specimens aredescribed and claimed in U.S. Pat. Nos. 5,747,344 and 5,948,687. Theentire disclosures of those two patents are herein incorporated byreference.

In recent years there have been significant advances in DNA/RNA testingof fecal matter. Present tests are very expensive often costing hundredsof dollars, and involve a whole stool specimen rather than a sample.

A need continues to exist for an inexpensive and easy-to-use fecal testwhich has a minimal incidence of false positives and can be readily usedin a doctor's office. The invention of the present application seeks tomeet that need.

SUMMARY OF THE INVENTION

In accordance with one aspect of the present invention, there isprovided a testing device including a first panel with three aperturesin the first panel; a second panel with three apertures in the secondpanel opposite the three apertures in the first panel; a sheet disposedbetween the first and second panels for receiving a specimen through theapertures, the sheet in the apertures in the first panel having firstand second and third portions disposed about a transverse axis of theapertures; first aperture covers mounted on the first panel andoverlying the apertures in the first panel; second aperture coversmounted on the second panel and overlying the apertures in the secondpanel, the first and second aperture covers being movable independentlyof each other to expose the first and second and third portions of thesheet. The first and second and third portions of the sheet are providedwith indicating means for locating where specimen is to be placed on thesheet. The indicating means in the second portion is comprised of one ormore zones which are removable from said sheet, and may be defined byperforations. The indicating means in the third portion is comprised ofa zone which is also removable from the sheet typically by way ofperforations and is impregnated with one or more compounds forpreventing degradation of DNA/RNA in a sample applied to the thirdportion.

According to a preferred aspect, the first and second panels arerectangular. In a further preferred aspect, the apertures in the firstpanel extend at right angles to the apertures in the second panel. Theapertures may be rectangular, square, round or oval.

Typically, the aperture covers in the first panel are hingedly mountedalong a hinge line extending transversely of the first panel, and theaperture covers in the second panel are hingedly mounted along a hingeline extending longitudinally of the second panel. The first, second andthird portions of the sheet may be divided by one or more dividingregions, which may comprise a hydrophobic strip.

In a further aspect, the first and second panels each have threeapertures, with the three apertures in the second panel being oppositethe three apertures in the first panel. Each of the three apertures inthe first and second panels has a respective aperture cover whichoverlies portions of the sheet in each of the three apertures. The firstand second panels typically have printed matter thereon, and an innersurface of the first and second aperture covers is generally providedwith. a non-stick wax layer. The sheet may if desired be supported on asupport panel disposed between the first and second panels.

In a further aspect, there is provided a method of analyzing a specimenusing a specimen-testing device as defined above. The method includes,comprises or consists essentially of the steps of obtaining a specimen;opening a first aperture cover on the first panel to expose the first,second and third portions through an aperture; smearing a portion of thespecimen on the first, second and third portions through the aperture;closing the first aperture cover to overlie the aperture; opening asecond aperture cover on the second panel to expose the first portion ofthe sheet carrying the specimen; and applying a reagent to the firstportion of the sheet. A zone of the second and third portions istypically removed from the sheet for further analysis. The specimen maybe a fecal specimen, a urine specimen, a blood specimen, a sputumspecimen, a body fluid specimen. or a DNA/RNA specimen.

The sheet may be a single piece of paper, typically filter paper, andmay be provided with one or more hydrophobic dividing strips separatingthe first, second and third portions to prevent or minimize possibleleakage of developing solution from the one portion to the otherportions. Alternatively, the first, second and third portions may becomprised of three separate pieces of filter paper each separated by ahydrophobic barrier. The paper sheet may be impregnated with reagent(e.g. guaiac) over the entire area thereof, or may be impregnated withreagent (guaiac) only on the first portion and plain unimpregnatedfilter paper for the second portion. The third portion is typicallyimpregnated with a compound selected from pH buffers, antibiotic(s), adisaccharide sugar (such as Trehalose), a drying agent, a diffusion gel,antibodies to blood or DNA/RNA, and mixtures thereof. These compoundsserve to stabilize DNA/RNA to reduce degeneration of the DNA/RNA.

The paper is typically high quality cotton to facilitate preservation ofDNA/RNA for analysis of the sample. The hydrophobic material may be waxor other suitable solid organic or inorganic material.

In another preferred aspect, the first and second portions are providedwith indicating means for locating where specimen is to be placed on thesheet through the apertures in the first panel, and where developingsolution is to be placed through the apertures in the second panel. Theindicating means may comprise printed circles or other shapes on thesheet as a visible indicator to the user of where to place the specimen.At least one of the indicating means, usually that in the second andthird portions, is preferably comprised of a perforated zone which isremovable from the sheet.

In accordance with a further aspect of the invention, the first panelhas three apertures extending transversely of the first panel and thesecond panel has three apertures opposite the three apertures in thefirst panel, which extend longitudinally of the second panel. In thisembodiment, a support panel for the sheet may be provided between thefirst and second panels with apertures corresponding to the apertures inthe first panel. Each of the three apertures in the first panel has arespective cover hingedly mounted along a hinge line extendinglongitudinally of the longitudinal axis of the panel and overlying arespective aperture and respective first and second portions of thesheet. Each of the three apertures in the second panel has a respectivecover which is hingedly mounted on the second panel along a hinge lineextending longitudinally of the second panel and overlies the apertures.

According to another preferred feature, the device may carry printedmatter on the first panel such as patient details and instructions foropening of the respective covers to reveal the apertures on which thespecimen is smeared. Printed matter may also be provided on the secondpanel, such as instructions to the doctor for conducting testing ofspecimens.

A further preferred feature of the device is that sticking of the coverto the specimen is prevented by providing the inside surfaces of therespective aperture covers with a non-stick coating. A typical exampleis a wax layer.

The present invention enjoys numerous advantages. In particular, thedevice is embodied in one card. which readily facilitates transferencebetween the doctor and the patient and between the doctor and anothertesting location, such as a laboratory. The device is easy to use by thepatient and is inexpensive to produce. A particularly importantadvantage is that the device allows a first test to be carried out bythe doctor and, in the event that a specimen is positive, or DNA/RNAtesting is indicated for other reasons such as family history orinflammatory bowel disease, subsequent testing can be carried out on thesame specimen.

The methodology involves amplifying the DNA/RNA and testing forabnormalities after separating from bacterial and human DNA/RNA. Inessence genormics, proteomics and laser flight technology are used tolook for changes compared to normal for tumor producing-genes, tumorsuppressor genes, whether they are expressed, biological markers, and afew genes and messengers which allow delay in the division of thenucleus to permit the gene material to be corrected or the cell to bedestroyed (apoptosis) such as p23. Genomics permits testing using amicro-array chip and amplification fluorescent system for up to 20,000amino acid sequences. Proteomics uses a gel diffusion technique and anapplied electric current to delineate different molecular weight andcharged proteins and further investigate those, which are not present inthe same amount as the normal control. Chip and laser flight technologymeasures the characteristics of weight and charge using a flighttechnology. Biological markers can be detected by immunoassay usingantibodies.

The third aperture consists of a high quality cotton paper with certainadditives present. In order to preserve.the stool specimen, the pHshould be maintained at around neutral, for example 6.5-7.5, typicallyabout 7.0. This is accomplished by using pH buffered paper which hasbeen impregnated with, for example, 50 ml 0.1 molar potassium dihydrogenphosphate and 29.1 ml of 0.1 molar NaOH. In order to prevent bacterialdestruction of the DNA/RNA, use of a solution of an antibiotic such asFlagyl in a dilution 1:10⁻⁴ is used to impregnate the paper. Cottonpaper can be impregnated with magnesium carbonate as a drying agent. Inorder to preserve the DNA/RNA, Trehalose, a disaccharide sugar, in adilution 1:10⁻⁴ 4 can be used to prevent the destruction of the DNA/RNAwhich occurs rapidly in untreated stool. The compounds allow for theprotection and preservation of DNA/RNA for periods typically up to 11years. The nature of the compounds varies, depending on whether thespecimen is stool or other biological fluid. For stool, the compoundwould for example include pH buffers, antibiotic(s), a disaccharidesugar such as Trehalose, a diffusion gel, antibodies to blood or DNA/RNAand a drying agent. The paper typically would be high quality cotton tofacilitate DNA/RNA testing of the sample. The additives will varydepending on the source of the specimen, but for stool would include pHand osmolarity buffers, antibiotic(s) and a disaccharide sugar such asTrehalose.

If it were indicated to proceed with a DNA/RNA test, the rectangularperforated area would be removed and an eluate obtained using. distilledwater and buffers which would be used to look for DNA/RNA abnormalities.Examples of these abnormalities are mutant K-ras, p53 tumor suppressorgene, BAT-26 micro satellite instability marker, long DNA/RNA, APC(Adenomatous polyposis coli). The sensitivity of the. current commercialversion using whole stool is approximately 65% for Colo-rectal Cancer(CRC), 30-40% for advanced adenomas, and there is a specificity of 95%.The use of the third aperture adds to conditions detected by a twoaperture system (two-tier test), since two entirely different methods ofdetecting cancer and polyps are involved. Thus, the two tier testidentifies about 3% of the screened group of patients who have bleedingin the stool, and this will detect about 90% of cancers and 70% ofadenomas. The third aperture will typically detect about 65% of thecolo-rectal cancers and 40% of polyps through the shedding of cancercells and there will be an overlap in patients because the thirdaperture will detect some cancers and adenomas that are not bleeding atthe time of testing. The high specificity of the second test will notadd greatly to the 3% who require colonoscopy. The net result is a testwith high sensitivity and specificity which avoids unnecessary expensiveand invasive tests as are carried out at present.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of a device of the invention showing the outsideconfiguration of the foldable sheet;

FIG. 2 is a plan view of the inside configuration of the foldable panelof FIG. 1;

FIG. 3 is a plan view of a simple receiving sheet which is positionableinside the foldable panel of FIG. 1 when the latter is folded;

FIG. 4 is a perspective view of the embodiment in partially openconfiguration comprised of a foldable panel of FIGS. 1 and 2 and asample receiving sheet of FIG. 3 therebetween; and

FIG. 5 is a plan view of a further embodiment showing the outsideconfiguration of the foldable sheet.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1 and 2, there is shown a foldable panel 70 of theinvention. The panel is typically made of paper or cardboard, but mayalso be fabricated of plastic. The panel has a first outer side 72 andan opposite inner side 74. The panel 70 has a fold line 76 extendingalong a longitudinal axis 78 forming a first portion 80 on one side ofthe fold line and a second portion 82 of the other side of the foldline. The first portion 80 is provided with three rectangular apertures84, 86, 88 extending transversely with respect to the longitudinal axis78. Each aperture has a respective cover 90, 92, 94 hingedly mounted tothe first portion 80 along a respective hinge line 96, 98, 100 extendingtransversely of the axis 78. Each cover 90, 92, 94 is hingedly movableindependently of the others between closed and open positions.

The second portion 82 includes three rectangular apertures 102, 104, 105extending longitudinally of the axis 78 and opposite the transverselyextending apertures 84, 86, 88. Aperture 102 is provided with a cover106, aperture 104 provided with a cover 107 and aperture 105 is providedwith a cover 109. Covers 106, 107 and 109 are each hingedly mountedalong a respective hinge line 110, 111, 112, each of which extendslongitudinally of the axis 78. Each cover 106, 107, 109 is movableindependently of the other between a closed portion and an openposition.

The first portion 80 is provided with locations 114 for completion ofdate(s) on which samples are collected from the patient and patientidentifying information 116. In addition, each cover 90, 92, 94 isprovided with specimen identification information 118 togetheroptionally with instructions for application of a specimen sample afterthe cover is opened.

The second portion 82 is provided with locations 120 for reportingresults of testing, together with boxes 122 for completion of actiontaken with respect to the patient and/or doctor. The covers 106, 107,109 are provided with respective information 124, 125, 126 regardingperson or entity conducting analysis of the specimen. Tabs 115 areformed on each cover to assist the user in opening the cover.

FIG. 2 shows the inner sides 74, 79 of the panel 70. The surfaces 75, 77are typically coated with a hydrophobic material, preferably awaterproof glue such as wax containing an adhesive. The purpose of thishydrophobic material is to prevent contamination or mixing of individualspecimens applied through an aperture into the region of an adjacentaperture. In this way, the risk of a specimen spreading and contactingother specimen(s) is minimized. The hydrophobic material also aids inminimizing sticking of the covers to the specimen.

FIG. 3 shows a sample receiving sheet 128 sized to be received betweenportions 80, 82 when folded over each other. Sheet 128 is typically madeof an absorbent material, usually filter or high grade cotton paper,which is impregnated with a reagent which will react with hemoglobincomponents from blood and a peroxide solution to form a coloredcompound. Examples of suitable reagents are guaiac, tetramethylbenzidene, orthotoluidine and other similar chromogens. In theembodiment illustrated herein, the reagent impregnated in the sheet isguaiac. For DNA/RNA testing, the compounds will vary depending on thesource of the specimen, but for stool would include pH and osmolaritybuffers, antibiotic(s), a diffusion gel, antibodies to blood or DNA/RNAand a disaccharide sugar, such as Trehalose.

To prevent seepage of reagent from one area to another, sheet 128 isprovided with strips of hydrophobic material 130, 131 such as waxextending longitudinally parallel to axis 132 and two strips ofhydrophobic material 134, 136 such as wax extending transversely of axis132 and crossing strips 130, 131. The intersecting pattern of strips130,131, 134, 136 defines nine regions 138, 140, 142, 144, 146, 148,154, 156, 158. Regions 144, 146, 148 are each provided with indicatingmeans 150, typically circular zones shown in dashed outline, to assistthe user in browsing where to smear the sample on the sheet. The zonesmay be provided with perforations 152 to enable the zones to be removedfrom the sheet 128 for subsequent analysis. The sheet 128 may, ifdesired, be supported on a support member (not shown).

The sheet 128 may be formed from one piece of absorbent paper withhydrophobic strips defining the regions 138, 140, 142, 144, 146, 148,154, 156, 158. Alternatively, the sheet 128 may be constructed fromdifferent absorbent papers, each optionally containing differentreagents, with the hydrophobic strips bonding the different paperstogether to form the sheet. In a further modification, the regions138,140,142,144,146, 148,154,156,158 may be comprised of differentpaper(s) of varying textures, and carrying different colors of reagent.Each region is then bonded together with hydrophobic material to formthe completed sheet 128.

DNA/RNA stool specimens undergo considerable amounts ofdegradation/digestion. There has been some study of this aspect by theDepartment of Criminal Justice. Dr. Liane R. Martin,.STR-Typing ofNuclear DNA/RNA for Human Fecal Matter Using the Qiagen QIAAMP® StoolMini Kit, describes the difference between the theoretical yield ofDNA/RNA (3.0×10⁵-6.0×10⁶].pg/ml stool. After a week, swabbing orexcision both yielded DNA/RNA under the conditions of water immersion (2hours), air dried for a week, frozen for a week and processed withoutthawing. All alleles matched that of the subject's reference sample.This means that the stool collected in the way described in this testwill be sufficient for testing. Additionally, work has been reported onpreservation of stools in rare animals which provides the data for theadditives suggested (Society for Conservation Biology, 16^(th) AnnualMeeting, Jul. 14-19, 2002).

The term “texture” as used herein in connection with the sheet 128 meansthat the fibrous structure of the sheet material, e.g. paper, may bevaried depending on the desired degree of adherence of the sample. Thepaper should be sufficiently absorbent so that specimen does not easilyseparate from the sheet after application thereto, for example as thespecimen dries out. Generally, the sheet (paper) is chosen such that thefibrous structure of the paper permits at least some of the sample topermeate through the paper and be visible on the other side to that onwhich the specimen is applied. Generally, the sheet material should besuch that at least about 20% by weight, for example about 25 to about50% by weight, of the specimen permeates through the sheet and isvisible on the other side.

FIG. 4 is a device of the invention constructed using a foldable panel70 and a sheet 128. The device is constructed by placing a sheet 128 onan inside surface 74 with the regions 138, 140, 142, 144, 146, 148, 154,156, 158 aligned with apertures 84, 86, 88. The panel 70 is then foldedalong fold line 76 to bring the inner surface 74, 79 into face-to-facecontact with each other, sandwiching the sheet 128 therebetween withregions in registration with apertures 84, 86, 88 and apertures 102,104, 105. Adhesive present on surface 74 or surface 79 or both permitsthe surfaces to be adhered to each other to maintain the resultingdevice in the folded closed state.

FIG. 5 shows an embodiment similar to that shown in FIG. 1 except thatthe second panel 82′ includes two rectangular apertures 102′, 104′extending longitudinally of the axis 78′ and opposite the transverselyextending apertures 84′, 86′, 88′. Aperture 102′ is provided with acover 106′, aperture 104′is provided with a cover 108′. Covers 106′ and108′ are each hingedly mounted along a respective hinge line 110′, 112′,each of which extends longitudinally of the axis 78′. Each cover 106′,108′ is movable independently of the other between a closed portion andan open portion.

The first portion 80′ is provided with locations 114′ for completion ofdate(s) on which samples are collected from the patient and patientidentifying information 116′. In addition, each cover 90′, 92′, 94′ isprovided with specimen identification information 118′ togetheroptionally with instructions for application of a specimen sample afterthe cover is opened.

The second portion 82′ is provided with locations 120′ for reportingresults of testing, together with boxes 122′ for completion of actiontaken with respect to the patient and/or doctor. The covers 106′ 108′are provided with respective information 124′, 126′ regarding person orentity conducting analysis of the specimen. Tabs 107′ are formed on eachcover to assist the user in opening the cover.

The invention has been described with reference to analysis of fecalsamples for stool occult blood. However, the device may be used forscreening and testing of other biological specimens, for example bloodand AIDS tests, urine tests, pregnancy tests and DNA/RNA tests. Otherbiological fluids can be usefully transported and conveniently stored onthe DNA/RNA or third aperture which in this aspect could be a singlewindow, or using that only or using the other apertures for apreliminary sensitive but not specific test (inexpensive) to befollowed, if positive, by the third aperture. Examples of this would beblood tests (genes for familial breast cancer, leukemia, other cancers,HIV, diabetes, morbid obesity, pregnancy, Hepatitis A,B,C) urine(pregnancy test, complications of pregnancy. Another aspect would beinexpensive storage of biological material—centrifuged specimen of cellsfrom urine, washings, ascitic fluid for later testing or us as adatabase (with patient's informed consent). Another aspect would bestorage of blood and other samples for DNA/RNA testing for specificdisorders (heart disease, atherosclerosis, diabetes, morbid obesity.

In use, where a fecal sample is to be analyzed, a cover 90 on the firstpanel 80 of the device is opened and a fecal specimen is smeared throughthe aperture on the first, second and third portions 138, 144.and 154 ofthe exposed sheet 128. The cover is then closed. A second fecal sampletaken at a different time as a result of a different bowel movement isthen smeared onto the first, second and third portions 140, 146, 156 ofthe sheet through the second aperture 86 on the first panel, and thecover 92 is closed. The third specimen from yet a different bowelmovement at a different time is smeared onto the first, second and thirdportions 142, 148, 158 through the third aperture 88 on the-first paneland the cover 94 is closed.

To conduct a first analysis, the cover 106 on the second panel 82covering the first portions on which specimen has been applied is openedand developer solution is applied to the circular zone 150 of each firstportion. If a specimen tests positive, as evidenced, for example, by thedevelopment of a blue color, the cover 104 on the second panel coveringthe second portions is opened together with the cover on the firstpanel, and the respective exposed perforated circular zone 150 of thesecond portion of the sheet carrying the positive specimen is removedwith both covers open, e.g. by being punched out of the sheet, andsubjected to further analysis (e.g. an immunochemical test).

For DNA/RNA testing, the device is used as follows. Upon indication toproceed with DNA/RNA testing, the cover 105 is opened and therectangular perforated area 154 is removed and an eluate obtained usingdistilled water and buffers, which is analyzed for DNA/RNAabnormalities. Examples of such abnormalities are mutant K-ras, p53tumor suppressor gene, BAT-26 micro satellite instability marker, longDNA/RNA, APC. Colo-rectal cancer has many DNA/RNA mutations associatedwith it and one test alone is not sufficient. The stool therefore has tobe examined for the presence of DNA/RNA with the mutations known tooccur with colo-rectal cancer. Similar analyses may be performed on theareas 156 and 158.

Modifications of the invention will be readily apparent to those skilledin the art. For example, embodiments comprising fewer than threeapertures in the first and second panels, or embodiments containing morethan three apertures in one or both panels, also fall within the scopeof the present invention.

In the above description, the apertures are illustrated as rectangular.However, any desired shape may be used, for example oval or circular.

While the invention has been described in connection with what ispresently considered to be the most practical and preferred embodiment,it is to be understood that the invention is not to be limited to thedisclosed embodiment, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the appended claims.

1. A specimen testing device, comprising: a first panel; at least twoapertures in said first panel; a second panel; at least two apertures insaid second panel opposite said at least two apertures in said firstpanel; a sheet disposed between said first and second panels forreceiving a specimen through said apertures, said sheet in saidapertures in said first panel having first, second and third portionsdisposed about a longitudinal axis of said apertures; first aperturecovers mounted on said first panel and overlying said apertures in saidfirst panel; second aperture covers mounted on said second panel andoverlying said apertures in said second panel; said first and secondaperture covers in said first and second panels being movableindependently of each other to expose said first, second and thirdportions of said sheet; said third portion of said sheet comprising oneor more compounds impregnated therein for preventing degradation ofDNA/RNA in a sample applied to said third portion.
 2. A device accordingto claim 1, wherein said first and second panels are rectangular.
 3. Adevice according to claim 1, wherein said apertures in said first andsecond panels extend longitudinally along said first and second panels.4. A device according to claim 1, wherein said apertures arerectangular.
 5. A device according to claim 1 wherein said apertures aresquare, round or oval.
 6. A device according to claim 1, wherein saidaperture covers in said first panel are hingedly mounted along a hingeline extending transversely of said first panel.
 7. A device accordingto claim 1, wherein said aperture covers in the second panel arehingedly mounted along a hinge line extending longitudinally of saidsecond panel.
 8. A device according to claim 1, wherein said first andsecond portions of said sheet are divided by a dividing region.
 9. Adevice according to claim 8, wherein said dividing region comprises ahydrophobic strip.
 10. A device according to claim 1, wherein saidsecond and third portions of said sheet are divided by a dividingregion.
 11. A device according to claim 10, wherein said dividing regioncomprises a hydrophobic strip.
 12. A device according to claim 1,wherein said first and second portions of said sheet are provided withindicating means for locating where specimen is to be placed on thesheet.
 13. A device according to claim 12, wherein at least one of saidindicating means is comprised of a zone which is removable from saidsheet.
 14. A device according to claim 13, wherein said zone is definedby perforations.
 15. A device according to claim 1, wherein said firstand second panels each have three apertures, said apertures in saidsecond panel being opposite said apertures in said first panel.
 16. Adevice according to claim 15, wherein each of said three apertures insaid first and second panels has a respective aperture cover whichoverlies said portions of said sheet in each of said three apertures.17. A device according to claim 1, wherein said first and second panelshave printed matter thereon.
 18. A device according to claim 1, whereinan inner surface of said first and second covers is provided with anon-stick wax layer.
 19. A device according to claim 1 wherein saidsheet is supported on a support panel disposed between said first andsecond panels.
 20. A method of analyzing a specimen using a specimentesting device including a first panel, at least two apertures in saidfirst panel, a second panel, at least two apertures in said second panelopposite said at least two apertures in said first panel, a sheetdisposed between said first and second panels for receiving a specimenthrough said apertures, said sheet in said apertures in said first panelhaving first, second and third portions disposed about a longitudinalaxis of said apertures, first aperture covers mounted on said firstpanel and overlying said apertures in said first panel, second aperturecovers mounted on said second panel and overlying said apertures in saidsecond panel, said first and second aperture covers in said first andsecond panels being movable independently of each other to expose saidfirst, second and third portions of said sheet, said third portion ofsaid sheet comprising one or more compounds impregnated therein forpreventing degradation of DNA/RNA in a sample applied to said thirdportion, said method comprising the steps of: (a) obtaining a specimen;(b) opening a first aperture cover on said first panel to expose saidfirst, second and third portions through an aperture; (c) smearing aportion of said specimen on said first, second and third portionsthrough said aperture; (d) closing said first aperture cover to overliesaid aperture; (e) opening a second aperture cover on said second panelto expose said first portion of said sheet carrying said specimen; (f)applying a reagent to said first portion of said sheet; and (g) testingfor DNA/RNA using said third portion.
 21. A method according to claim20, wherein said third portion is removed from said sheet and analyzedfor DNA/RNA abnormalities
 22. A method according to claim 21, whereinsaid abnormalities are mutant K-ras, p53 tumor suppressor gene, BAT-26micro satellite instability marker, long DNA/RNA, APC.
 23. A methodaccording to claim 20, wherein a zone of said second portion is removedfrom said sheet for further analysis.
 24. A method according to claim20, wherein the specimen is a fecal specimen, a urine specimen, a sputumspecimen, a body fluid specimen or a blood specimen.